title: Learning from recent trials and shaping the future of acute heart failure trials.
abstract: The last decade of acute heart failure (HF) research is characterized by disappointments in large phase 2 and 3 pharmacologic studies of therapeutics including calcium-sensitizing agents and antagonists of endothelin, vasopressin, and adenosine. As a result, pharmacologic management for acute HF has changed little in recent years, and adverse event rates remain higher than in chronic HF. Despite neutral results in many acute HF trials, recent studies including RELAX-AHF, ASTRONAUT, and PRONTO have highlighted the role of appropriate timing of patient enrollment, targeting the "right" patients, and selecting appropriate end points and sites. We describe lessons learned from recent trials in acute HF and outline strategies to improve the potential for success in future trials. This review is based on discussions between scientists, clinical trialists, and regulatory representatives at the 9th Global Cardio Vascular Clinical Trialists Forum in Paris, France, from November 30 to December 1, 2012.
authors.affiliation: Duke University, Durham, NC. Electronic address: robert.mentz@duke.edu.
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Mentz
authors.forename: Gary Michael
authors.initials: GM
authors.lastname: Felker
authors.forename: Tariq
authors.initials: T
authors.lastname: Ahmad
authors.forename: William Frank
authors.initials: WF
authors.lastname: Peacock
authors.forename: Bertram
authors.initials: B
authors.lastname: Pitt
authors.forename: Mona
authors.initials: M
authors.lastname: Fiuzat
authors.forename: Aldo P
authors.initials: AP
authors.lastname: Maggioni
authors.forename: Mihai
authors.initials: M
authors.lastname: Gheorghiade
authors.forename: Yuki
authors.initials: Y
authors.lastname: Ando
authors.forename: Stuart J
authors.initials: SJ
authors.lastname: Pocock
authors.forename: Faiez
authors.initials: F
authors.lastname: Zannad
authors.forename: Christopher M
authors.initials: CM
authors.lastname: O'Connor
mesh_terms: D000208:Acute Disease; D002986:Clinical Trials as Topic / Q000379:methods*; D019468:Disease Management; D005544:Forecasting; D006333:Heart Failure / Q000628:therapy*; D006801:Humans